Mallampati and Brodsky Classification and Children's Risk for Sleep Related Breathing Disorder.

OBJECTIVE: To evaluate associations between Mallampati and Brodsky classification and children's risk for sleep related breathing disorder (SRBD). STUDY DESIGN: This study recruited well-children 2-11 years old and legal guardians over 18 years from a community dental clinic. Modified Mallampati classification (IIV) and Brodsky grade (0-4) were classified by a single dentist. Guardians completed the validated 22-item pediatric sleep questionnaire (PSQ) to identify children at risk of SRBD. Associations between Mallampati and Brodsky classifications with risk for SRBD as defined by PSQ were determined by Chi-square, Kruskal-Wallis, and simple logistic regression models. RESULTS: Of 150 children included (M=5.9 years), 76 (51%) female, 108 (72%) Latino/Hispanic, 82 (55%) were classified as Mallampati class I or II, 68 (45%) class III or IV, 119 (79%) were identified as Brodsky grade 0, 1, or 2, and 31 (21%) grade 3 or 4. Children with Mallampati class III and IV and Brodsky grade 3 and 4 collectively had a 5.24-fold and 2.8-fold increase in SRBD risk per PSQ compared to children with class I and II and grade 1 and 2, respectively. CONCLUSION: Mallampati classification may be a quick, non-invasive screening tool to improve identification and timely intervention for children at risk of SRBD.

A Proof-of-concept Study Using Quantitative Sensory Threshold Analysis to Compare Two Intraoral Topical Anesthetics.

PURPOSE: CTY-5339A is an investigational topical anesthetic spray containing 14% benzocaine/2% tetracaine in a metered canister. Each spray delivers ∼0.2 mL of solution. This double-blind, randomized, crossover study compared the local anesthetic effect of CTY-5339A versus 14% benzocaine alone by using 2 quantitative sensory threshold experimental pain paradigms on the maxillary gingiva: pin prick test pain intensity (PPT PI) and heat pain threshold (HPT). METHODS: American Society of Anesthesiology Class 1 and 2 subjects (N = 50) were enrolled in this study. To qualify for the study, subjects were tested on the anterior maxillary gingiva with both PPT and HPT. Subjects had to report a PPT PI of ≥3 on a 0 to 10 numeric pain intensity scale on 1 of 2 consecutive pin pricks separated by 10 s, with at least one score ≥4. After PPT, mean HPT following 2 ramps in the same location had to be ≤ 46.5 °C, with each ramp beginning at 35 °C and an automatic cutoff of 50.6 °C. For treatment visits, subjects were randomly administered either 1 spray of CTY-5339A or 14% benzocaine to the anterior maxillary gingiva within 3 weeks of screening and then the alternative treatment 5 days to 2 weeks later. PPT PI and HPT were recorded immediately before drug application. After drug administration, PPT PI was recorded every minute through 5 min. Commencing at 5 min, PPT PI and HPT were recorded every 5 min through 60 min. For assessment of methemoglobin concentrations, venous blood (5 mL) was drawn from the antecubital fossa both before and 60 min after drug application. Oxygen saturation was recorded via pulse oximetry at baseline and every 10 min. FINDINGS: The AUCs for pain intensity difference from 0-30 and 0-60 min after PPT and HPT differences were significantly greater (P < 0.0001) for CTY-5339A compared with 14% benzocaine. Multiple time points on the time-action curves for PPT PI difference and HPT difference statistically (P < 0.05) favored CTY-5399A. Methemoglobin and oxygen saturation levels did not change compared with baseline after dosing with either treatment. IMPLICATIONS: Recommended doses of CTY-5339A provided significantly more profound and sustained local anesthesia than 14% benzocaine when applied to the maxillary gingiva. Significant changes in methemoglobin or oxygen saturation concentrations did not occur for either drug. ClinicalTrials.gov identifier: NCT03233737.